US 200801 07742A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2008/0107742 A1 Hare (43) Pub. Date: May 8, 2008

(54) COMPOSITIONS AND METHODS FOR Publication Classification REMOVINGURUSHOLAND TREATING THE RESULTING SKIN CONDITION (51) Int. Cl. A6II 3L/25 (2006.01) (76) Inventor: William D. Hare, Princeton, NJ (US) A6II 3L/045 (2006.01) A6IR 9/14 (2006.01) A6IP 7/00 (2006.01) Correspondence Address: (52) U.S. Cl...... 424/489: 514/729: 514/692 WILLAM DOUGLASHARE (57) ABSTRACT 3 ANDERSON LANE The present application is directed to various compositions to PRINCETON, NJ 08540 (US) treat the itching and conditions that result from contracting (21) Appl. No.: 11/930,098 poison ivy, poison oak, and poison Sumac, as well as other plant and Substances that contain Substances that lead to askin (22) Filed: Oct. 31, 2007 reaction but that upon removal alleviate the symptoms of the condition. In particular, the compositions described herein Related U.S. Application Data are useful for removing urushiol after it has contacted the skin. The compositions include granules or other Scrubbing (62) Division of application No. 10/906,491, filed on Feb. means to reach the urushiol in the skin, a mixture of Surfac 23, 2005. tants to form a complex with the urushiol, counter-irritants to provide a soothing sensation to the irritated skin, and other (60) Provisional application No. 60/547,038, filed on Feb. functional ingredients to provide additional benefits to the 24, 2004. individual who has contacted urushiol. US 2008/01 07742 A1 May 8, 2008

COMPOSITIONS AND METHODS FOR REMOVING plants produce small clusters of ivory-white fruits, each with URUSHOL AND TREATING THE RESULTING a papery outer exocarp, a soft waxy mesocarp and a hard SKIN CONDITION Stony endocarp Surrounding the seed. The fruits of related shrubs such as squaw bush, lemonadeberry (Rhus integrifo TECHNICAL FIELD OF THE INVENTION lia) and Sugar bush (Rhus ovata) are reddish with a sticky pubescent exocarp. The old adage about poison oak and poi 0001. The technical field of the invention relates to con son ivy is quite accurate: "Leaves of three, let it be; berries cepts, compositions, and methods for removingurushiol from white, poisonous sight.” the skin, after a reaction has occurred, to thereby eliminate the irritant and itching, and allow the skin to heal. 0007 Freshly cut stems exude a sticky, terpene oleoresin that oxidizes and polymerizes into a shiny black lacquer BACKGROUND OF THE INVENTION resembling pruning sealer. The resinous sap is produced in resin canals of the stems, roots, leaves and flowers. Cross 0002 Poison Ivy, Poison Oak and Other Plants that Con sections of poison oak stems show distinct concentric annual tain Urushiol rings (ring-porous wood). Numerous resin canals appear as 0003 Poison ivy (Toxicodendron radicans), poison oak tiny black dots and are confined to the phloem layer just inside (Toxicodendron diversilobum), poison Sumac, and various the bark. Dark resin canals (appearing as black striations) also other similar plants cause allergic contact dermatitis in occur in the waxy mesocarp of the fruits just beneath the people. These plants are variously found throughout the papery skin. Abundant resin canals is one of the reasons United States. A subspecies of poison ivy (T. radicans; ssp. poison oak and poison ivy are placed in the genus Toxicoden dron rather than the older genus Rhus. Toxicodendron is also Divaricatum) is native to southern Baja California and the updated generic name for poison Sumac (Tvernix) and the Sonora, Mexico. Reports show that there are at least four Japanese lacquer tree (T. vernicifluum), the commercial native species of Toxicodendron in North America, including Source of natural lacquer. The resin canals also contain seven subspecies of poison ivy, and three species in Malaysia urushiol, the insidious allergen that gives poison oak its bad and China, including two subspecies of poison ivy, one in reputation. The name is derived from “urushi’, Japanese China and one in Japan. name for lacquer made from the sap of the Japanese lacquer 0004 Poison oak is a widespread deciduous shrub tree (“kiurushi' or “urushiki'). throughout the mountains and Valleys of California, generally at elevations below 5,000 feet. In some locations it grows as 0008. In addition to poison oak, poison ivy and poison a climbing vine with aerial (adventitious) roots that adhere to Sumac, a number of other species in the Sumac Family con the trunks of oaks and Sycamores. Poison oak also forms tain urushiol mixtures. In Japan, dermatitis reactions have dense thickets in chaparral and coastal Sage scrub, particu been reported from contact with lacquered objects (from larly in central and northern California. Poison oak regener Japanese lacquer tree) Such as bar tops, rifle stocks and toilet ates readily after disturbances Such as fire and the clearing of seats. Dermatitis has also been reported in people handling land. Rocky Mountain poison oak (Toxicodendron rydbergii) mangoes (Mangifera indica), shells of cashew nuts (Anacar occurs in canyons throughout the Western United States and dium occidentale), the Rengas tree (Gluta renghas), Burmese Canada. Because the two species of Western poison oak often lacquer tree (Melanorrhoea usitata) and two attractive Car exhibit a viney growth form, they are considered to be sub ibbean shrubs, Metopium toxiferum and Conocladia dodo species of Eastern poison ivy. naea. The name Rengas actually refers to several genera of large Malaysian trees with resinous sap that blackens when 0005 The pinnately trifoliate leaves typically have three exposed to the air. Urushiols also occur in the seeds of Ginkgo or five leaflets, the terminal leaf being on a slender rachis biloba (Ginkgoaceae) and in several genera of the Proteaceae. (e.g., a stalk or petiolule). Eastern poison ivy often has a longer rachis and the leaflet margins tend to be less lobed and 0009 Urushiol Oil, Structure and Transport Serrated (i.e., less "oak-like'). In the similar-appearing squaw 0010 Urushiol is the broad term given to the substance in bush (Rhus trilobata) the terminal leaflet is sessile (without a the sap of poison ivy (Toxicodendron radicans), poison oak stalk). Like many members of the Sumac Family (Anacardi (Toxicodendron diversilobum), poison Sumac, and other aceae) new foliage and autumn leaves often turn brilliant plants that causes allergic contact dermatitis in people. shades of pink and red due to anthocyanin pigments. In the Urushiol is a clear, Sticky oil, causes an allergic reaction, and Eastern United States poison ivy is often mistaken for another is potent even on dead or dried plants, which causes urushiol common native called Virginia creeper (Parthenocissus quin to be hazardous even during the winter months. Some reports quefolia), which has a similar growth habit and attractive estimate that between approximately 50% and 70% of the autumn foliage, but with five leaflets rather than three. Vir U.S. population is allergic to urushiol. In fact, there is some ginia creeper belongs to the grape family (Vitaceae) along clinical evidence shows that no one is completely immune to with the common wild grape (Vitis girdiana). the urushiol but that the sensitivity is a matter of degree: some 0006. In poison ivy, during the late spring loose clusters people are sensitive to Small amounts while others react only (panicles) of small greenish-white flowers are produced in the to large amounts. Poison oak and poison ivy account for an leaf axils. Functional male and female flowers are typically estimated ten percent of lost work time in the U.S. Forest produced on separate plants (dioecious), or occasionally, uni Service. In fact, hundreds of fire fighters who battle summer sexual and bisexual flowers may occur on the same plant and fall blazes in California's coastal ranges are so severely (polygamous). Male flowers contain five stamens and a rudi affected that they are unable to work. People who breathe in mentary pistil Surrounded by five cream-colored petals and the Smoke and soot may develop serious inflammation of five sepals. Female flowers have a fertile pistill (gynoecium) respiratory mucous membranes. Because of the serious eco and reduced, sterile stamens. During Summer and fall, female nomic impact due to lost employment time, poison oak inju US 2008/01 07742 A1 May 8, 2008

ries' are covered by Workers’ Compensation Insurance in ivy. Poison ivy mostly contains a mixture of four Saturated California. It is reported that the monetary cost of this afflic pentadecylcatechols (with 15-carbon side chain), while poi tion is approximately one percent of the state's workers’ Son oak contains a mixture of four heptadecylcatechols (with compensation budget. 17-carbon side chain). 0011 Reports indicate that urushiol is actually a mixture 0015. As indicated above, the side chain may be saturated of phenolic compounds that are known as catechols, which or unsaturated with one, two, or three double bonds. Accord are potent benzene ring compounds having a long side-chain ing to some studies, the immune reaction and specificity of of 15 or 17 carbon atoms. The side chain may be saturated or the catechol molecule is a function of the long side-chain. As unsaturated with one, two, or three double bonds. It is might be expected, the urushiol can vary based on the plant in reported that the immune reaction and specificity of the cat which it is found. For example, the urushiol from poison oak echol molecule is determined by the long side-chain. Poison contains mostly catechols with 17-carbon side-chains (hep oak urushiol contains mostly catechols with 17 carbon side tadecylcatechols). In contrast, the urushiol from poison ivy chains (heptadecylcatechols), while poison ivy and poison and poison Sumac contain mostly 15 carbon side-chains (pen Sumac contain mostly 15 carbon side-chains (pentadecylcat tadecylcatechols). echols). These compounds are illustrated below. Formula I 0016. It has been reported that urushiol is found in only the depicts the chemical structure of urushiol in which there are resin canals of the plant and that it will be found on the plant's five possibilities for the variable R: outer surfaces only if the leaves and stems are bruised or attacked by chewing? sucking insects Such that it can reach the Formula I outer Surface. Although nonvolatile, it may be carried in ash OH and dust particles and as minute droplets in Smoke from burning foliage. Many Surprised people and firefighters have OH learned to their detriment that although urushiol is nonvola tile, it is carried in ash and dust particles and as minute droplets in Smoke from burning foliage. Thus, carefully clear (CH2)-R ing poison ivy and other urushiol-containing plants with dili gence to avoid contact, but then burning them creates a urushiol-containing Smoke that disperses the urushiol over a R—(CHKH) I great area, including the eyes and lungs. Firefighters regularly R=HC=CH(CH2)CH II encounter this hazard when fighting forest fires. R=HC=CHCH-CH=CH(CH-)-CH III 0017. The Body’s Reaction to Urushiol R-HC=CHCH-CH=CHCH-CHCH IV 0018) Urushiol causes an irritating skin reaction on many R-HC=CHCH-CH=CHCH-CH=CH, V people. The body's immune system treats urushiol as foreign 0012 Formula II depicts the chemical structure of the and attacks the complex of urushiol-derivatives with skin pentadecylcatechols in which there are four possibilities for proteins. In the absence of the immune attack, urushiol would the variable R: be harmless. The reaction, an itchy rash with clear blisters, is variable in severity among people, and can vary from year to year on the same individual. Once the skin has been exposed Formula II OH to urushiol it is only a matter of hours, usually 24 to 72, before rash breaks out. Any area that comes into contact with the oil OH will react, except the mucous membranes, such as lips, mouth, and inside of the nose. The rash, Rhus dermatitis, starts off as red, swollen patches, with a few small fluid-filled blisters. As the reaction intensifies, the blisters become larger, and then break down and weep. The whole area becomes covered with an oozing, Scaling crust. Contrary to popular REC15H31, C15H29, C15H27 and C15H25 belief, the rash itself does not “spread like an infection. It is 0013 Formula III depicts the chemical structure of the the unknowing transfer of the oil to other parts of the body by heptadecylcatechols in which there are four possibilities for touching that gives the spreading affect. Once the oil is com the variable R: pletely removed from skin and clothing, no further rash will result. Some rashes will appear Sooner than others depending on the sensitivity of the skin area and the amount of urushiol Formula III contacted. OH 0019. The poison ivy reaction can be reduced by changing OH clothing immediately after contact and washing the exposed skin with Soap and water. It is reported that if a person can wash all the oil off exposed skin within 5 minutes of contact, R no reaction will occur. Even water from a running stream can be an effective cleanser. Some people are so sensitive to urushiol that it only takes a molecular trace of urushiol (two REC17H35, C17H33, C17H31 and C17H29 micrograms or less than one millionth of an ounce) on the skin 0014. The above figures illustrate the chemical structure to initiate an allergic reaction. Even the amount on a Surface of urushiols found in resin canals of poison oak and poison the size of pinhead is sufficient to cause rashes in 500 sensi US 2008/01 07742 A1 May 8, 2008 tive people. Approximately 80-90 percent of adult Americans a particular allergenic chemical. Such as the urushiol of poi will get a rash if they are exposed to 50 micrograms of purified Son oak. T-cells patrol the body's circulatory system looking urushiol, which is a minute amount when considering that one for invading cells and viruses. grain of table salt weighs about 60 micrograms. An urushiol 0024 PHASE II (Elicitation): Once urushiol is absorbed residue on the skin is difficult to wash off and may be spread into the skin during a Subsequent encounter with poison oak, by Scratching. Contrary to popular belief, it is not spread an effector T-cell may encounter it bound to a Langerhan's through blister fluids. It is a relatively stable compound and cell and attach to it by a specific recognition system. The can retain its potency for years in the absence of oxidation— effector T-cell then produces more clones of itself and herbarium specimens 100 years old have been known to cause releases special proteins called lymphokines (cytokines) dermatitis. Urushiol is readily transferred from contaminated which attract a legion of different white blood cells, including clothing, objects and fur of animals. Moreover, it readily “cell engulfing macrophages and cytotoxic (“killer') penetrates the epidermal layer of the skin where it binds to T-cells. The killer T-cells are also produced in regional lymph proteins of deeper skin cell membranes. Before the protein nodes during the Elicitation phase, and according to some bond can occur the catechol (Formula IV) is oxidized to a textbooks, they also have urushiol receptors on their mem more reactive quinone (Formula V) in which the two OH branes. The new army of white blood cells releases lytic groups are replaced by double-bonded oxygens, as illustrated enzymes and protein toxins (perforins) which destroy every in the reaction schematic FIGURE below. thing in the vicinity including membrane-bound urushiol and other skin cells, thus producing ablistering rash. Fluid oozes from the blood vessels and lymphatics (edema) and cell death OH O and necrosis (breakdown) of skin tissue occurs. Milder OH O effects range from redness (vasodilation) and itching (nerve OXIDATION injury) to small blisters (vesicles and bullae). He 0025 There is some natural immunity to poison oak. Sen C17H35 C17H35 sitization depends on the chance meeting of a special effector T-cell (with correct receptor site) and the poison oak aller Formula IV Formula V gen—a painful biochemical rendezvous. A person may not have effector T-cells with the special receptor for urushiol or perhaps a person that has relatively few effector T-cells 0020. The above illustration shows the chemical structure with precise poison oak receptor may never encounter the of poison oakurushiol (heptadecylcatechol) and its oxidized urushiol allergen. The allergen may be absorbed and “reactive' quinone. The reactive quinone bonds to white degraded before the T-cells find it. Immunity to poison oak blood cell membranes deep in the skin. with age, exposure and homeopathic remedies may involve 0021. In the conjugated state (bound to cell membranes) suppressor T-cells which inhibit or block the action and repro urushiol is virtually impossible to wash off. By itself the duction of other T-cells. Circulating IgG immunoglobulin urushiol molecule (also called a hapten) probably would not antibodies that block the T-cell receptor forurushiol may also initiate a full-blown immune response, but when attached to be involved. the cell membrane it becomes a “warning flag” that attracts 0026. Since the HIV virus attacks helper T-cells, persons patrolling T-cells. afflicted with the deadly disease AIDS have a serious defi 0022 Poison oak urushiol causes a complicated delayed ciency in cellular (T-cell) immunity. AIDS patients may not allergic reaction with the body's immune system. It is tech have problems with poison oak dermatitis and this likely nically classified as a cell-mediated immune response and the reflects their decreased cellular immunity. In fact, one treat "peak misery' may not appear until days or weeks later. It is ment for AIDS patients is to try to sensitize them to another quite different from the primary irritants of nettle and euphor allergenic chemical (dinitrochlorobenzene) in order to stimu bias, the effects of which are immediate. The following hypo late T-cell production. thetical “two-phase' scenario for poison oak dermatitis is 0027 Treatments for Urushiol-Induced Contact Dermati summarized from the scientific literature. PHASE I (Induc tis tion): Initial contact with poison oak may result in urushiol penetrating the stratified squamous epithelial cells of the skin 0028 Scientists have tried many homeopathic remedies and binding to large dendritic (branched) white blood cells in made from extracts of poison oak. Some products, such as the epidermis called Langerhan's cells, as illustrated in FIG. poison oak tablets and droplets, were withdrawn from the 1, which illustrates a hypothetical mechanism for the poison market because of severe allergic reactions in hypersensitive people. One area of desensitization research involves oral oak scenario: a delayed action, cell-mediated immune pills and intramuscular injections of related or modified response. urushiol: A molecule similar enough to urushiol to have the 0023 The Langerhan's cell (with urushiol allergen and same immunological effect, but different enough to avert its MHC protein on its membrane) migrates to a nearby lymph excruciating side effects. Other research may lead to a vac node where clones of special white blood cells, called effector cine that blocks the specific urushiol T-cell receptor and T-cells, are programmed to recognize urushiol. Some immu immunizes "high risk” people against urushiol for periods of nology textbooks refer to these clones of T-cells, with time. In fact, Allergene, a biotech company in San Mateo, urushiol receptor sites on their membranes, as “helper Calif. has successfully produced a hybridoma (fused lympho T-cells.” There are literally millions of effector T-cells (helper cyte and carcinoma cell) that makes urushiol-binding mono T-cells) roaming throughout the blood and lymphatic system, clonal antibodies. These antibodies prevented sensitized mice each with special receptor molecules on their membranes for from reacting with urushiol. US 2008/01 07742 A1 May 8, 2008

0029. The complete list of topical treatments for poison oxidation ofurushiol at the initial site of contact before it has oak and poison ivy includes an array of materials, including penetrated the skin. Once urushiol binds to the protein of skin bleach, morphine, kerosene, buttermilk, and gunpowder. cell membranes, these creams would have little effect on the Lotions, creams and sprays containing anti-inflammatory Subsequent immune response. corticosteroids (hydrocortisones) are generally accepted as being potential effective agents to relieve painful, itching 0033. There are a number of commercially available prod rashes. Serious outbreaks may require medical attention and ucts. One product, called Tecnu Oak-n-Ivy(R) Cleanser, is now hospitalization. The ideal therapy when exposed to poison marketed through forestry Supply catalogs. Tecnu is a crude oak or ivy is to wash the contaminated areas thoroughly, distillate of gasoline and contains a mixture of organic Sol unfortunately most ordinary bath soaps have little effect on vents and wood pulp by-products which remove terpene res removing the resinous sap. There are some reports that soaps ins and urushiol from the skin. Thorough rinsing with water is with added moisturizers and oils together with brisk rubbing recommended. Similarly, other organic solvents, including may even spread the urushiol, thereby increasing the area of rubbing alcohol, likely would remove the urushiol residue. allergic response. Strong laundry soaps, such as Fels Naptha, However, if the allergen has already penetrated the epidermal may also spread the allergen and be harsh on sensitive skin. layer and bonded to deeper skin cells it is too late. Another Some sources recommendantipruritic (anti-itch) agents such product that claims to remove urushiol from the skin, even as calamine lotion for mild cases. after a rash has developed, is called ZanfelTM. Yet another product developed for the U.S. Forest Service is called Ivy 0030. Another remedy for the discomfort of itching poison Block R. It is in the form of an aerosol spray or lotion con oak and ivy lesions is a "pore minimizer acne treatment with taining activated bentonite clay used in antiperspirants. Ivy 2% salicylic acid (available from several manufacturers, BlockR) is described as forming a barrier that both prevents including Neutrogena R and Johnson & Johnson). A poultice urushiol from touching the skin and chemically binds with it made from the resinous flowers and leaves of gum plant So it becomes inactive. Another blocking agent, called (Grindelia robusta) was commonly used by Indians and early StokoGard Outdoor CreamR, is a fatty acid ester and is avail settlers in California to relieve inflammation and itching. able through industrial Supply houses and through pharmacist Native Americans also made concentrated poultices from who can order it from Stockhausen, Inc. of Greensboro, N.C. boiled leaves of the common shrubs yerba Santa and manza nita (Eriodictyon and Arctostaphylos spp.), and from the thick 0034. A number of background sources on poison ivy roots of mule ears (Wvethia longicaulis), a resinous, balsam include: scented Sunflower with large basal leaves. Other reported http://waynesword-palomar.edu/ww0802.htm, naturopathic remedies to relieve the inflammation and itching of poison oak rashes include Salves made from the crushed http://chemweb.calpoly.edu/chem/bailey/377/PapersF2000/ leaves of Aloe vera and narrow-leaf plantain (Plantago lan Dana/, and ceolata). Some herbal manuals listapoultice made from juicy stems of the North American jewelweeds (Impatiens capensis Dana Longinetti, Chem 377-Drugs and Poisons, Fall 2000. and I. pallida). Succulent wildflowers that grow with poison ivy in the Eastern states; although its efficacy is questionable SUMMARY OF THE INVENTION and possibly amply disproved. 0035) In one general aspect there is provided a composi 0031) A recent editorial in Mushroom The Journal (Winter tion for applying to skin that has been in contact with 1994-95) discussed a mycological cure for poison oak rash by urushiol. The composition includes a first compound, a sec rubbing fungi such as Boletus and Polyporus on the affected ond compound, and one or more counterirritants. The first skin. This treatment is based on the fact that freshly cut pieces compound has a group containing one or both of a carbon of mushrooms, apples and potatoes turn dark when exposed chain of less than nine carbonatoms or more than nine carbon to the air. The actual mechanism for this blackening process atoms (one or more phenol ethoxylates having a carbon chain involves the oxidation of phenolic compounds in the tissues of less than nine carbon atoms or more than nine carbon of these pieces by the enzyme tyrosinase. The resulting atoms). The second compound has a group containing one or quinones rapidly polymerize into a brown residue. Placing both of a carbon chain of less than eleven carbon atoms or the pieces under water prevents this “unsightly oxidation. In more than eleven carbon atoms (one or more sodium sarco fact, chefs add lemon juice, which contains the strong reduc sinates having a carbon chain of less than eleven carbonatoms ing agent ascorbic acid; this keeps the phenolics reduced. or more than eleven carbon atoms). Since urushiol is a phenolic compound, tyrosinase would 0036) Embodiments of the composition may include one probably also detoxify it. The enzymes might also reduce the or more of the following features. For example, the one or spreading of urushiol to other parts of the body by deactivat more phenol ethoxylates may further include a carbon chain ing it at the initial site of exposure. of less than nine carbon atoms. The one or more counterirri 0032. There is a report that an even more specific and tants may include one or more of the counterirritants potent oxidase forurushiol, catechol 2.3 oxidase, oxidizes the described herein. The composition may further include one or ring structure between carbon atoms it 2 and #3 and thereby more granular materials. The composition may further destroying the molecule. In the study, a bacterial gene was include one or more of a topical anesthetic, an antifungal cloned and expressed to produce this recombinant enzyme, agent, an antibiotic agent, and an antiviral agent. The com which oxidized the urushiol in vitro within seconds. The position may further include one or more granular means. The report further notes that when applied to skin the enzyme granular material or means may be one or more of granules, sometimes prevented a rash, but only if the urushiol was beads, microspheres, grit, and pumice. The granular material inactivated before penetrating the epidermis. The efficacy of may be one or more of a polymer, sand, glass, and jojoba patented creams containing oxidase enzymes depends on the beads. The polymer may be one or more of a polyethylene, a US 2008/01 07742 A1 May 8, 2008 polypropylene, and a polystyrene. The granular means may 0043. Form, Application, and Treatment. The composi be porous. The granular means may be a pad, cloth or other tions can be in the form of a Solid soap; a thick or highly scrubbing means. Viscous cream; a thin, runny, or low viscosity cream; or a 0037. In another general aspect there is provided a com composition of viscosity in between these extremes. The position for applying to skin that has been in contact with composition can be in the form of a backpacker's or hiker's urushiol. The composition includes one or more nonionic kit, Such as a tube of the treatment material and separate Surfactants; one or more anionic Surfactants; and a counter wipes, e.g., alcohol, aqueous, or other liquid-type wipes. irritant. The surfactants are selected such that the form a Further details of the form are provided below as they relate to complex with urushiol Such that it can be removed upon the implementation of the granular materials. The solid soap scrubbing and application of a fluid. can include the ingredients described herein, including the 0038. The details of one or more embodiments of the counterirritant, the granules and the Surfactants. Scrubbing compositions are set forth in the accompanying drawings and the affected area with the soap and a fluid, e.g., water, rubbing the description below. Other features and advantages of the alcohol, or other suitable solvent, results in the granules compositions will be apparent from the description, the draw abrading the skin, the counterirritant providing a comforting ings, and the claims. sensation, and the Surfactants forming a complex with the DESCRIPTION OF THE FIGURES urushiol. Subsequently running water, rubbing alcohol or other suitable solvent over the skin then removes the urushiol 0.039 FIG. 1 is a perspective view of skin undergoing a from the skin. This treatment can be repeated multiple times reaction with urushiol. over a short time or over a number of hours or days. Generally, DETAILED DESCRIPTION the treatment should be repeated if there is itching of the skin. 0040 General Composition. The invention relates to com 0044) A thick or highly viscous or granular cream can positions and methods useful for removing urushiol from the include the ingredients described herein, including the coun skin, before or after a reaction to the urushiol has occurred, to terirritant, the granules and the Surfactants. By spreading the thereby eliminate the irritant and itching, and allow the skinto cream over the area in the presence or absence of a fluid, e.g., heal. The invention also relates to processes for making the water, rubbing alcohol or other suitable solvent, and then composition and the various forms in which the compositions scrubbing the area results in the granules abrading the skin, can be made. In one implementation, a composition includes the counterirritant providing a comforting sensation, and the one or more nonionic Surfactants, one or more anionic Sur factants and, optionally, one or more counter irritants, gran Surfactants forming a complex with the urushiol. Subse ules or the like, fillers, preservatives, thickening agents, mois quently running water, rubbing alcohol, or other Suitable sol turizers, colorants, emulsifiers, wetting agents, detergents, vent over the skin then removes the urushiol from the skin. and alkalinizing agents. The Surfactants are selected Such that Again, this treatment can be immediately repeated if there is they cover a ranges of sizes such that some or all of the continued itching, or later if an itching sensation develops. surfactants will provide complexes with the urushiol, deriva The thick or viscous cream can be applied with a cloth or pad, tives, and related compounds. The complexes then can be in addition to simply using one's hands. If the cloth or pad is removed by washing with a fluid. rough, the granules are optional because the rough cloth or pad accomplishes the abrasion caused by the granules. 0041. The compositions may also include one or more of a topical analgesic and anesthetic agents, an antibiotic agent, an 0045. A thin, runny low viscosity cream or fluid can antifungal agent, an antiviral agent, an astringent agent, and include the ingredients described herein, including the coun those agents approved by the US FDA for the treatment of terirritant, the granules and the Surfactants. By first applying poison ivy, poison oak and poison Sumac, as described and the cream or fluid to the effected area and then scrubbing defined herein below. The surfactants interact with the results in the granules abrading the skin, the counterirritant urushiol on the skin and when washed off of the skin remove providing a comforting sensation, and the Surfactants forming the urushiol along with them. The counter-irritants provide a a complex with the urushiol. In addition to merely using one's sensation on the skin that causes relief to the itching caused by hand, the scrubbing can be accomplished by using, for the urushiol. The granules provide immediate relief to the itching and roughen the skin to allow the Surfactants to bond example, a pad or cloth. The pad or cloth can be rough or or interact with the urushiol so that it can be removed upon Smooth. If using a rough pad or cloth, the granules are washing. The topical analgesic and anesthetic agents provide optional because the rough pad or cloth causes the abrasion some degree of longer term relief to the itching. The antibi caused by the granules. otic, antifungal, and antiviral agents provide longer term pre 0046) Surfactants (Nonionic Surfactants, Anionic Surfac vention against infection. tants) 0042. Further, the compositions optionally may include one or more of the following depending on the desired physi 0047 Surfactants are compounds used to emulsify and cal form, intended use, marketing objective, or other purpose: solubilize oils, greases and other Substances. In the compo alkalinizing agent, humectant, detergent, wetting agent, anti sitions described herein, their primary use is to solubilize the bacterial agent, stabilizer, emulsifier, antifungal agent, colo urushiol so that it can be removed from the skin. The surfac rants, moisturizer, thickening agent, preservative, filler, kera tants can be a variety of ionic Surfactants that have sufficient tolytic agent, protectant agent, vasoconstrictor agent, charge and/or length to allow the Surfactant to interact with astringent agent, local anesthetic agent, analgesic/anesthetic/ the urushiol. For example, the following anionic Surfactants antipruritic agents, and wound healing agent. may be used: Sodium Cocoyl Sarcosinate, Potassium lauryl US 2008/01 07742 A1 May 8, 2008 sacrosinate (Potassium N-Lauroyl, Methylglycinate), having lates consists of a fat-loving (lipophilic) and a water-loving Formula VI (hydrophilic) part. As it appears from the below FIGURE, these Substances are composed by a phenol structure to which can bee bound one (or two) alkyl chains with a chain length of Formula VI usually nine carbon atoms (nonylphenol ethoxylates), more rarely by eight carbon atoms (octylphenol ethoxylates). The CH(CH2)C-N-CHCOOK phenol structure and the alkyl chain constitute the lipophilic part of the Substance. A chain of ethoxylate groups has also CH3 been bound to the phenol structure. The length of this ethoxy late chain may vary much between various types of alkylphe nol ethoxylates. The ethoxylate chain constitutes the hydro 0.048 Anionic surfactants or detergents include Cocyl Sar philic part of the substance. cosine, Lauroyl Sarcosine, Myristoyl Sarcosine, Oleoyl Sar cosine, Stearoyal Sarcosine, Sodium Cocoyl Sarcosinate, 0051 Because of their structure nonylphenol ethoxylates Sodium Lauroyl Sarcosinate, Sodium Myristoyl Sarcosinate, are able to reduce the Surface tension between two phases, e.g. Ammonium Cocoyl Sarcosinate, and Ammonium Lauroyl air/water, oil/water or water/biological membranes. This is Sarcosinate, Ammonium Lauryl Sulfate, Disodium Laureth the property which causes the extensive use of the Substances Sulfosuccinate, Potassium Cocoyl Glycinate, Sodium and as used herein provides a means to remove the urushiol Cocoyl Isethionate, Sodium Lauryl Sulfate, Sodium Methyl from the skin. The surface active properties of the nonylphe Cocoyl Taurate, Sodium Stearoyl Lactylate, Sodium Cocoyl nolethoxylates are used in a large number of products, such as Glutamate, Sodium Isostearoyl Lactylate, Sodium Lauroyl detergents and cleaning materials, insulants, pesticides, paint Sarcosinate, Sodium Lauroyl Glutamate, Sodium Lauroyl and lacquer as well as plastic. In pesticides nonylphenol Lactylate, Sodium Methyl Cocoyl Taurate, TEA-Lauryl Sul ethoxylates are used as “carriers of the mixture of active fate, TEA-Cocoyl Glutamate, a mixture of Coconut acid/ substances which implies that they partly dissolve the active Arginine/Potassium, a mixture of Sodium Cocoyl Glutamate Substances in the pesticides, partly increase the absorption of and Disodium cocoyl glutamate, and a mixture of Sodium these Substances in the target organism. The increased Stearoyl Glutamate and Sodium cocoyl glutamate, ammo absorption implies that the quantity of active Substances can nium laureth Sulphate, ammonium lauryl Sulfate, dealauryl be reduced without modifying their effect. Sulfate, sodium laureth Sulfate, sodium myreth Sulfate, 0.052 Considering just one of these ethoxylates, non sodium lauryl sulfate, tea lauryl sulfate, sodium C14-16 ole ylphenol ethoxylate has a molecular formula of fin Sulfonate, sodium Xylenesulfonate, and Sodium Laureth CHCH (OCH2CH)nOH and synonyms for this com Sulfate (SLES). pound include POE nonyl phenyl ether; polyoxyethylene 0049 Other surfactants that can be used are ethoxylates, nonylphenyl ether; nonylphenyl polyethyleneglycol ether, such as octyl phenol ethoxylates, Lauryl Alcohol Ethoxylate, nonionic; ethoxylated nonylphenol; macrogol nonylphenyl Ceto-Stearyl Alcohol Ethoxylate, Cetyl Alcohol Ethoxylate, ether; and polyethylene mono (nonylphenyl)ether glycols. Stearyl Alcohol Ethoxylate, Tridecyl Alcohol Ethoxylate, Applications for these nonylphenol ethoxylates include as Oley Alcohol Ethoxylate, Myristyl Alcohol Ethoxylate, nonionic Surfactants used as emulsifiers and in formulating Decyl Alcohol Ethoxylate, Oley-Cetyl Alcohol Ethoxylate, emulsifier blends. They also may be used as a wetting agents, Nonyl Phenol Ethoxylate, Octyl Phenol Ethoxylate, Dodecyl dispersants, stabilizers, sanitizers and defoaming agents. The Phenol Ethoxylate, Stearic Acid Ethoxylate, Lauric Acid end applications for these ethoxylates include agrochemical Ethoxylate, Oleic Acid Ethoxylate, Palmatic Acid Ethoxy emulsifers, industrial cleaners, metal cleaners, textiles, paper late. Butyric Acid Ethoxylate, Castor Oil Ethoxylate, Poly de-inking, drilling products and detergents. They also may be ethylene Glycol, and alkyl phenol ethoxylates, such as non used as an intermediate for the synthesis of anionic Surfac Oxynol 12, nonoxynol 30, nonoxynol 4, nonoxynol 6, tantS. nonoxynol 9, octoxynol 10, and octoxynol 12. Others are Cocyl Sarcosine, Lauroyl Sarcosine, Myristoyl Sarcosine, 0053 Some examples of various nonylphenol ethoxylates Oleoyl Sarcosine, Stearoyal Sarcosine, Sodium Cocoyl Sar and their physical characteristics are provided below. Using their physical characteristics described below, one of skill in cosinate, Sodium Lauroyl Sarcosinate, Sodium Myristoyl the art can use the data as a guide, for example, to select the Sarcosinate, Ammonium Cocoyl Sarcosinate, and Ammo suitable ethoxylates to tailor the physical characteristics of nium Lauroyl Sarcosinate. the composition. 0050. It has been said that alkylphenol ethoxylates and alkylphenol are the rubric of a number of phenol ethoxylates 0054 The physical and chemical properties for 10 mol and phenol compounds. Nonylphenol ethoxylates are alky nonylphenol ethoxylate are as follows: physical state, white lphenolethoxylates with an alkyl chain consisting of nine paste; melting point, 1° C.; specific gravity, 1.06; Solubility in carbon atoms. Alkylphenol ethoxylates are so-called non water, Soluble (Soluble in methanol, Xylene. Insoluble in ionic Surfactants (tensides). Quantitatively, they represent Kerosene); pH, 6.3 (10% sol.); viscosity (CPA), 240 at 25°C.: one of the most used groups of tensides in the world. About and stability, stable under ordinary conditions. 80% of the total consumption is made up by nonylphenol 0055. The physical and chemical properties for 2 mol non ethoxylates which are alkylphenol ethoxylates with an alkyl ylphenol ethoxylate are as follows: appearance, clear oily chain consisting of nine carbon atoms. Octylphenol ethoxy liquid; specific gravity, 1.03+0.010; cloud point, (1% HO), lates, which are also used as Surfactants, represent a very Small part of the total consumption. As the use of nonylphenol less than 25°C.; and approximate HLB, 5.7. ethoxylates is predominant, this name will be used in the 0056. The physical and chemical properties for 4 mol non following. The chemical structure of nonylphenol ethoxy ylphenol ethoxylate are as follows: appearance, clear oily US 2008/01 07742 A1 May 8, 2008

liquid; specific gravity, 1.03+0.010; cloud point (1% HO), logues, and derivatives thereof: fatty acid derivatives of less than 25°C.; and approximately HLB, 9. amino acids, oligopeptides, and polypeptides; glyceride derivatives of amino acids, oligopeptides, and polypeptides; 0057 The physical and chemical properties for 5 mol non acyl lactylates; monoacetylated tartaric acid esters of ylphenol ethoxylate are as follows: appearance, clear oily monoglycerides, monoacetylated tartaric acid esters of dig liquid; specific gravity, 1.035+0.010; cloud point, (1% HO), lycerides, diacetylated tartaric acid esters of monoglycerides, less than 25°C.; and approximate HLB, 10. diacetylated tartaric acid esters of diglycerides; Succinylated 0.058. The physical and chemical properties for 6 mol non monoglycerides; citric acid esters of monoglycerides; citric ylphenol ethoxylate are as follows: appearance, clear oily acid esters of diglycerides; alginate salts; propylene glycol liquid; specific gravity, 1.04+0.010; cloud point (1% HO), alginate; lecithins and hydrogenated lecithins; lysolecithin less than 25°C.; and approximate HLB, 11. and hydrogenated lysolecithins; lysophospholipids and 0059. The physical and chemical properties for 8 mol non derivatives thereof; phospholipids and derivatives thereof; ylphenol ethoxylate are as follows: appearance, clear oily salts of alkylsulfates; Salts of fatty acids; sodium docusate; liquid; specific gravity, 1.06+0.010; cloud point (1% HO), and mixtures thereof. less than 25°C.; and approximate HLB, 12. 0069) Hydrophobic Surfactants 0060. The physical and chemical properties for 10 mol 0070 Hydrophobic surfactants may be, for example, one nonylphenol ethoxylate are as follows: appearance, clear oily or more of alcohols; polyoxyethylene alkylethers; fatty acids; liquid; specific gravity, 1.065+0.010; pH, 6.3 (10% Sol.); glycerol fatty acid monoesters; glycerol fatty acid diesters; hydroxyl number, 86-91; color, APHA, 30 max; and approxi acetylated glycerol fatty acid monoesters; acetylated glycerol mately HLB, 13. fatty acid diesters, lower alcohol fatty acid esters; polyethyl ene glycol fatty acid esters; polyethylene glycol glycerol fatty 0061 The physical and chemical properties for 12 mol acid esters; polypropylene glycol fatty acid esters; polyoxy nonylphenol ethoxylate are as follows: appearance, paste; ethylene glycerides; lactic acid derivatives of monoglycer specific gravity, 1.07+0.010; cloud point (1% HO), 78-83° ides; lactic acid derivatives of diglycerides; propylene glycol C.; and approximate HLB, 14. diglycerides; Sorbitan fatty acid esters; polyoxyethylene Sor 0062) The physical and chemical properties for 14 mol bitan fatty acid esters; polyoxyethylene-polyoxypropylene nonylphenol ethoxylate are as follows: appearance, paste; block copolymers, polyethyleneglycols as esters or ethers, specific gravity, 1.07+0.010; cloud point (1% HO), 92-99 polyethoxylated castor oil; polyethoxylated hydrogenated C.; and approximately HLB, 15. castor oil, polyethoxylated fatty acid from castor oil or poly 0063. The physical and chemical properties for 30 mol ethoxylated fatty acid from castor oil or polyethoxylated fatty nonylphenol ethoxylate are as follows: appearance, Solid; acid from hydrogenated castor oil. specific gravity, 1.08+0.010; cloud point (1% H2O), greater 0071 Nonionic Surfactants than 100° C.; and approximate HLB, 17. 0072. Nonionic surfactants may be, for example, one or 0064. The physical and chemical properties for 50 mol more alkylglucosides; alkylmaltosides; alkylthioglucosides; nonylphenol ethoxylate are as follows: appearance, Solid; lauryl macrogolglycerides; caprylocaproyl macrogolglycer specific gravity, 1.08+0.010; cloud point (1% H2O), greater ides, polyoxyethylene alkyl ethers; polyoxyethylene alky than 100° C.; and approximate HLB, 18. lphenols; polyethylene glycol fatty acid esters; polyethylene glycol glycerol fatty acid esters; polyoxyethylene Sorbitan 0065. The chemical formula of nonylphenol ethoxylate is fatty acid esters; polyoxyethylene-polyoxypropylene block illustrated below in Formula VII: copolymers; polyglycerol fatty acid esters; polyoxyethylene glycerides; polyoxyethylene sterols, derivatives, and ana Formula VII logues thereof; polyoxyethylene vegetable oils; polyoxyeth ylene hydrogenated vegetable oils; reaction products of poly ols and at least one member of the group consisting of fatty acids, glycerides, vegetable oils, hydrogenated vegetable oils, and sterols; Sugar esters, Sugarethers; Sucroglycerides; coco nut amidopropylamine oxide, alkylglycoside 8 and mixtures thereof. 0073. Another of the surfactants that is of particular inter estin the compositions described herein is nonoxynol-9 (non ylphenoxypolyethoxyethanol) available from Triton N101, 0.066 Other anionic surfactants that can be used are the Sigma, UK. Nonoxynols are used as non-ionic Surface active methyl taurate esters, a group of high flash foam mild anionic agents, acting as Surfactants in numerous cosmetic products Surfactants useful in all personal care products, and include and antiseptic preparations. This surfactant functions as a Sodium methyl cocoyl taurate, sodium cocoyl isethionate, disinfectant is in a variety of products ranging from baby and sodium methyl oleyl taurate. wipes to laundry detergent. It was invented for use as a con traceptive but nonoxynol-9 was reported to help prevent sexu 0067. Another surfactant that can be used is Delonic EAB ally transmitted diseases (STDs) such as chlamydia, gonor 95, a modified mixed alcohol ethoxylate (DeIONIC EAB-95 rhea, and herpes by killing spermand cells in the vaginal tract. from DeFOREST Enterprises, Inc.) It is reported to kill the human immuno deficiency virus in the 0068. Other ionic surfactants may be selected from one or test tube, according to laboratory tests of commercial sexual more of alkyl ammonium salts; bile acids and salts, ana products. As little as 0.05 percent of nonoxynol-9 in a solution US 2008/01 07742 A1 May 8, 2008

stops HIV from reproducing, while a 1 to 5 percent concen content of calamine); (b) witch hazel, 10 to 50 percent; and (c) tration may kill cells harboring dormant HIV. They have been Zinc oxide, within a concentration range of 5 to 25 percent by found to be irritants or sensitisers and their photosensitising weight perdosage unit. Other astringent agents recognized by effect has been widely recognized. Acting as an irritant in the the US FDA include: acetone; alcohol; alum, ammonium; compositions described herein provides some relief to the alum, potassium; aluminum chlorhydroxy complex; aromat itching caused by the urushiol. Formula VIII illustrates the ics; benzalkonium chloride; benzethonium chloride; ben chemical structure of nonoxynol-9: Zocaine; benzoic acid; boric acid; calcium acetate; camphor

Formula VIII

HC or

0074 Amphoteric Surfactants gum, clove oil; colloidal oatmeal; cresol; cupric sulfate; euca lyptus oil; eugenol; ferric subsulfate (Monsel's Solution); 0075 Amphoteric surfactants also can be used in the com honey; isopropyl alcohol; menthol; methyl salicylate; position. Examples of amphoteric Surfactants include diso oxyquinoline Sulfate; P-t-butyl-m-cresol; peppermint oil; dium cocoamphodipropionate, cocamidopropyl betaine, and phenol; polyoxyethylene laurate; potassium ferrocyanide; a mixture of disodium cocoamphodiacetate a sage oil; silver nitrate; sodium borate; sodium diacetate; talc; 0076 Wound Healing Agent tannic acid glycerite; thymol; topical starch, Zinc chloride; Zinc oxide; Zinc phenolsulfonate; Zinc Stearate; and Zinc sul 0077. The composition also may include an agent that fate. functions as a wound healing agent. Examples of wound heating agents include allantoin, carbamide peroxide in anhy 0085 Examples of other astringent agents include: (a) drous glycerin, water Soluble chlorophyllins, and hydrogen aluminum acetate, (b) aluminum sulfate, and (c) witch hazel. peroxide in aqueous Solution. These agents are regulated by the US FDA as skin protectant drug products at 21 CFR Part347. To comply with these FDA 0078 Analgesic, Anesthetic, and Antipruritic Agent regulations, these astringent agents should be used at the 0079 The composition also may include analgesic, anes following concentrations for each ingredient: (a) aluminum thetic, and antipruritic agents. A local anesthetic agent pro acetate, 0.13 to 0.5 percent in the resulting solution to be used duces local disappearance of pain, burning, itching, irritation, by the consumer; (b) aluminum sulfate, 46 to 63 percent (the and/or discomfort by reversibly blocking nerve conduction concentration is based on the anhydrous equivalent); and (c) when applied to nerve tissue in appropriate concentrations. witch hazel. Products containing aluminum acetate are An antipruritic agent is topically (externally) applied and labeled as follows: For temporary relief of minor skin irrita relieves itching by depressing cutaneous sensory receptors. tions due to poison ivy, poison oak, poison Sumac, and insect Such agents include: (a) camphor 0.1 to 3 percent; (b) juniper bites. tar 1 to 5 percent; (c) menthol 0.1 to 1 percent. 0086 Vasoconstrictor Agent 0080 Local Anesthetic Agent 0087. The composition also may include a vasoconstrictor 0081. The compositions may also include a local anes agent, an agent that causes temporary constriction of blood thetic agent. An analgesic, anesthetic agent may be one or vessels. Suitable vasoconstrictor agents include one or more more topically (externally) applied agents that relieve pain by of the following: (a) ephedrine sulfate 0.1 to 1.25 percent; (b) depressing cutaneous sensory receptors. Some Suitable local epinephrine 0.005 to 0.01 percent; (c) epinephrine hydrochlo anesthetic agents are described by the US FDA at 21 CFR ride 0.005 to 0.01 percent; and (d) phenylephrine hydrochlo 346.10 and include the following agents used at the following ride 0.25 percent. concentrations: (a) Benzocaine 5 to 20 percent; (b) Benzyl alcohol 1 to 4 percent; (c) Dibucaine 0.25 to 1 percent; (d) 0088 Protectant Agent Dibucaine hydrochloride 0.25 to 1 percent; (e) Dyclonine 0089. The composition also may include a protectant hydrochloride 0.5 to 1 percent; (f) lidocaine 2 to 5 percent; (g) agent that provides a physical barrier, forming a protective Pramoxine hydrochloride 1 percent: (h) Tetracaine 0.5 to 1 coating over skin or mucous membranes. Examples of pro percent; and (i) Tetracaine hydrochloride 0.5 to 1 percent. tectant agents that may be used as a sole protectant include: (1) aluminum hydroxide gel; (2) cocoa butter, and (3) glyc 0082 Astringent Agent erin in a 20- to 45-percent (weight/weight) aqueous solution 0083. The composition may also include an astringent so that the final product contains not less than 10 and not more agent. An astringent agent is applied topically (externally) to than 45 percent glycerin (weight/weight); (4) hard fat; (5) the skin or mucous membranes for a local and limited protein kaolin; (6) lanolin; (7) mineral oil; (8) petrolatum; (9) topical coagulant effect. Suitable astringent agents include one or starch; and (10) white petrolatum. more of the following: 0090. Examples of protectant agents that may be used in 0084 (a) calamine, within a concentration range of 5 to 25 combination with other protectants include: (1) calamine not percent by weight per dosage unit (based on the Zinc oxide to exceed 25 percent by weight per dosage unit (based on the US 2008/01 07742 A1 May 8, 2008

Zinc oxide content of calamine); (2) cod liver oil, provided skin layers. Some are intended to work by setting up a contrast that the product is labeled so that the amount of the product to the pain and sensations of arthritis (a counter-irritant): for that is used in a 24-hour period represents a quantity that example, by generating heat that might counter arthritis pain provides 10,000 U.S.P. units of vitamin A and 400 U.S.P. by distracting the body's attention, or numbing the response units of cholecalciferol; (3) shark liver oil, provided that the to arthritis. Other reports characterize counter-irritants as product is labeled so that the amount of the product that is inducing local inflammation for the purpose of relieving used in a 24-hour period represents a quantity that provides inflammation in deeper or adjacent tissues. In other words, 10,000 U.S.P. units of vitamin A and 400 U.S.P. units of they substitute one kind of inflammation for another. These cholecalciferol; and (4) zinc oxide not to exceed 25 percent by agents do not cure, but make the fundamental condition more weight per dosage unit. tolerable. 0091 Keratolytic Agent 0099 Counterirritants are divided into four categories by 0092. The composition also may include a keratolytic the FDA as listed below. agent. The agents cause descquamation (loosening) and debri 0.100) 1. Irritants that produce redness: turpentine oil, dement or sloughing of the Surface cells of the epidermis. methyl salicylate, strong ammonia Solution and ally) isothio Such agents include: (a) alcloxa 0.2 to 2 percent and (b) cyanate resorcinol 1 to 3 percent. 0.101) 2. Irritants that produce vasodilation: methyl nico 0093 Granular Material tinate and histamine 0094. The composition can include granular material or 0102) 3. Irritants that produce a cooling sensation: men similar agents that function as a roughening means to thol and camphor roughen, penetrate, or scuff the skin and otherwise help the 0.103 4. Irritants that do not produce redness: capsaicin Surfactants penetrate to the uSushiol. The sizes of the granular materials can vary within the product applied to the skin. The 0.104) The counter-irritant is provided in the compositions granular means include, for example, one or more of gran to provide a pain relief effect. The counter-irritant provides a ules, beads, microspheres, grit, and pumice and can be made paradoxical pain-relieving effect by producing less severe of for example, one or more of a polymer, sand, glass, and painto counter more intense pain. Counter-irritants generally jojoba beads. The polymer may be, for example, one or more are topical agents applied near painful or irritated sites to of a polyethylene, a polypropylene, and a polystyrene, or any produce a mild local inflammatory reaction. As a result, the other Suitable polymer. Other roughening means also can be deep-seated pain or itching is relieved. The intensity of the used instead of or along with the granular materials. For response depends on the counter-irritant used, its concentra example, a scrub pad can be used as a roughening means by tion, and the duration of contact with the skin. The action of placing the composition on the skin and/or scrub pad and counter-irritants in relieving pain is reported to have a strong rubbing the afflicted area with the scrub pad. The composition psychological component achieved through a pleasant or can be used alone or with the addition of water. After rubbing Strong aroma. the afflicted area for a brief period, the individual washes the 0105 Almost immediately upon application, a counter afflicted area with water, or other liquid-based or liquid irritant initially provides a feeling of coolness, followed by a containing means, to partially or completely remove the com sensation of warmth. This is due to the counter-irritant (e.g., position and urushiol. In place of a scrub pad or granular menthol) causing blood vessels to dilate. The intensity of the material, a cloth, pad, brush, or other roughening means may response depends on the concentration and duration of con be used. tact with the skin. 0.095 The granular materials can be porous and in the 0106 Tiger Balm. One suitable counter-irritant to use in pores can include one or more of Surfactants, therapeutic the compositions described herein is known as Tiger Balm. agents (e.g., antibiotics and antifungals), fluids, and solvents. Tiger Balm, a nonprescription drug applied to the skin or one These materials are released into the skin during the scrub or more of its individual ingredients may be used in the bing of the effected area. In so doing, they form a complex compositions described herein. The ingredients in Tiger Balm with the urushiol (i.e., Surfactant), treat the area (therapeutic include Menthol, Camphor, Cajeput oil, Peppermint oil, agent to prevent infections), and/or aid in removing the com Clove oil, Petrolatum, and Paraffin. plex (i.e., fluid such as water). These materials can be filled into the pores by, for example, soaking or spraying the mate 0.107 Capsaicin. Capsaicin is derived from the seeds and rial onto the granules. membranes of various plants in the Nightshade family. It is the most active ingredient in hot chilli peppers and capsicum: 0096. For example, as the granules should be large enough it is what makes them hot. Its use for arthritis is basically as to be effective and it has been recommended that granules in a counter-irritant. However, it has also been suggested that it the range of 5 to 50 microns are suitable, although larger might work by depleting a Substance from the nerves that granules also will be effective in many circumstances. helps transmit pain messages to the brain. One use of capsai cin creams is for arthritis. These creams also are used for 0097 Counter-Irritants several other conditions causing pain on the skin, including 0.098 Counter-irritants are externally applied agents that nerve pain from diabetes (neuropathy), pain after breast cause a reversible, transient, mild inflammation or irritation removal (mastectomy), and postherpetic neuralgia (continu of the skin to relieve pain or itching beneath the site of ing pain after an attack of shingles). Capsaicincreams are also application. While their mechanism of action is not com sometimes used for psoriasis where it is used to relieve itch pletely known, it is believed the sensation they produce on the ing, Scaling, redness and Soreness from psoriasis. It provides skin masks the pain or itching occurring more deeply in the a similar effect in the compositions described herein. More US 2008/01 07742 A1 May 8, 2008 over, studies from three trials showed that some capsaicin 0118 (h) mint (can be a skin irritant and cause contact creams were able to relieve pain and tenderness from osteoar dermatitis); thritis, and perhaps also from rheumatoid arthritis. About half the people trying capsaicin cream do not likeO the heat cap 0119 (i) colleus barbatus (member of the mint family: can saicin generates, and many find that it is so strong for them be a skin irritant); that it stings or burns. This sensation is one of the reasons that 0120 () cornmint (also known as wild mint; it can be a capsaicin is used in the compositions described herein. skin irritant); 0108) Another counter-irritant is thuja, from Thuja Occi 0121 (k) spearmint oil (fragrant, volatile oil that can cause dentalis (Biotae orientalis), and includes 1% volatile oil skin irritation and allergic reactions); including thujone, pinene, caryophyllene; pinipicrin, a bitter principle; flavonoid glycoside, mucilage, tannin, and wax. It 0.122 (i) patchouli (fragrant oil derived from mint; it con also is reported as having as its constituents thujone (60%), tains eugenol and can be a skin sensitizer and irritant); and fenchone, camphor, Sabinene, and pinene. Besides being a 0123 (m) peppermint (both the oil and the extract can counter-irritant, it also has the properties of being an astrin have antimicrobial properties (Source: Journal of Agricul gent, alternative, anthelmintic, diaphoretic, hemostatic, anti tural and Food Chemistry, July 2002, pages 3943-3946), and pyretic, and emmenagogue. It provides a slightly cold sensa can also have an irritating, sensitizing effect on skin (Source: tion upon application. Thuja is also believed to have an Natural Medicines Comprehensive Database, www.natural antiviral activity. Thuja's active principle, a volatile oil called database.com)). thujone, is reported to act on the muscles of the uterus and Native Americans drank a tea of the inner bark to promote 0.124. Another formulation that can be used as a counter menstruation. It has a role in the treatment of psoriasis and irritant in the compositions described herein is known as rheumatism as a counter-irritant, improving local blood Sup dentilinimentum aconiti compositum N.F. This formulation ply and easing pain and stiffness. contains 36 percent menthol and 13.5 percent chloroform in tincture of aconite. It is described as being a powerful 0109) Another counter-irritant is a composition that counter-irritant and local anesthetic used in neuralgic condi includes menthol 7.5%, isopropyl alcohol, water, pepper tions of the gums and in toothaches. A similar formulation mint, eucalyptus and can beformulated as a spray or a roll-on. contains 2.2 percent each of menthol and iodine and 16.5 This formulation is said to provide a nerve blocking effect, act percent chloroform dissolved in tincture of aconite. It is used as an analgesic and counter irritant. Upon application, it pro for similar properties to the above but is less actively counter vides a soothing cold and then warm feeling that will last from irritant but more antiseptic. one to five hours depending on the severity of the condition and amount applied. This can be used in compositions 0.125. Another counter-irritant that may be used is cajuput described herein. Oil (Dose: 0-06 to 0-2 ml. (1 to 3 minims). This counter irritant is a colourless, yellow, or green oil with an agreeable 0110 Mint (Mentha spp), peppermint, and spearmint. The camphoraceous odour and a bitter, aromatic, camphoraceous oil of peppermint has been reported to be antimicrobial and taste, obtained by distillation from the fresh leaves and twigs antiviral against Newcastle disease, herpes simplex, vaccinia, of certain species of Melaleuca Such as M. leucadendron and Semliki Forest and West Nile viruses. Menthol is an allergic M. minor (Myrtaccac). It contains 50 to 65% w/w of cineole. sensitizer that may cause hives. The menthol in oil of pepper Wt per ml. 0-910 g. to 0-923 g. Soluble 1 in 2 of alcohol mint is an effective local anesthetic. It increases the sensitiv (80%), becoming less soluble with age; miscible with alcohol ity of the receptors in the skin that perceive the sensation of (90%). Cajuput oil is used externally as a stimulant and mild coolness and reduces the sensitivity of the receptors that counter-irritant in rheumatism. In the compositions described perceive pain and itching (e.g., form urushiol). Menthol is herein, cajuput oil, like the other counter-irritants, provides a also a counterirritant, causing the Small blood vessels under sensation that relieves the itching caused by the urushiol. It is the skin to dilate, increasing the flow of blood to the area and described in various Pharmacopeias, including India, Spain, making the skin feel warm. When applied as part of a skin and Switzerland. lotion, the skin feels cool for a few minutes, then warm. Some example of mint or its derivatives and constituents are as 0.126 Another counter-irritant that may be used in the follows: compositions described herein is Nutmeg Oil (01. Myrist.: Myristica Oil: Essence de Muscade; Atherisches Muskatol). 0111 (a) mentha piperita (peppermint): Dose: 0-6 to 0-2 ml. (1 to 3 minims). It is a volatile oil 0112 (b) mentha spicata (spearmint oil); obtained by distillation from nutmeg. Physically, it is a col orless or pale yellow liquid with an odor and taste of nutmeg. 0113 (c) mentha viridis (spearmint oil); It is scarcely distinguishable from volatile oil of mace and 0114 (d) melissa officinalis (balm mint); frequently no commercial distinction is made between the two. Wit per ml. 0-860 to 0-895 g (West Indian oil) and 0-885 0115 (e) menthol (derived from peppermint; it can have to 0-922 g. (East Indian oil). West Indian oil is soluble 1 in 4 the same irritating effect as peppermint on skin (Source: of alcohol (90%), East Indian 1 in 3. Nutmeg Oil is known to Archives of Dermatologic Research, May 1996, pages 245 be a mild counter-irritant and is sometimes used in liniments 248)); and hair lotions. Sp. Myrist. (B.P.C. 1949). Spirit of Nutmeg. Oil of nutmeg 10 ml., alcohol (90%) to 100 ml. Dose: 0-3 to 0116 (f) menthone (major constituent of peppermint); 1-2 ml. (5 to 20 minims). Terpeneless Oil of Nutmeg (B.P.C. 0117 (g) menthyl lactate (used as a cooling agent and 1934). 01. Myrist. Deterpenat. Nutmeg oil concentrated in fragrance in cosmetics; it is a derivative of menthol and is vacuo until reduced to about one-fifth of its volume. 1 fl.oz. Supposed to be less irritating than menthol); Is equivalent in flavour to about 5 fl.oz. of natural oil. It is US 2008/01 07742 A1 May 8, 2008 described in various Pharmacopeias, including Belgium, FDA's Tentative Final Monograph on skin protectant drug Germany, India, Switzerland, and the U.S. products for Over-The-Counter (OTC) human use was pub 0127. Another counter-irritant is clove oil (B.P.) (01. lished in the Federal Register (Volume 48, No. 32, pp. 6820 Caryoph.; Esence de Girofle; Nelkenol; Esencia de clavo) 33 and Volume 55, No. 11, pp. 25240-81). Based on the wide Dose: 0-06 to 0-2 ml. (1 to 3 minims). Physically, it is a use and clinical acceptance of Allantoin, as well as published colorless or pale yellow liquid with the characteristic odor reports in the literature, the FDA approved the following and taste of clove, obtained by distillation from clove. It statements for non-prescription, drug products containing darkens with age and on exposure to light. It contains 85 to Allantoin at 0.5% to 2.0%: 90% V/v of eugenol. Wit per ml. 1-041 to 1-054 g; soluble 1 in 0.132 1. For the temporary protection of minor cuts, 2 of alcohol (70%); miscible with alcohol (90%) and with scrapes, burns and Sunburn. ether. Clove oil is applied externally as a rubefacient and counter-irritant. A liniment containing 1 part of clove oil and 0.133 2. Helps prevent and temporarily protects chafed, 2 parts of olive oil has been used to relieve pain in neuralgia. chapped, cracked, or wind-burned skin and lips. It is described in various Pharmacopeias including Chile, China, CZ., Egypt, France, Germany, Hungary, India, Japan, 0.134 3. Relieves dryness and softens cold sores and fever Jug., Mexico, Spain, Switzerland, and U.S. blisters. 0128. Another counter-irritant is spiritus sinapis NF 0.135 4. Helps treat and prevent diaper rash. Protects (Spirit of Mustard Sp. Sinap.). This counter-irritant contains chafed skin/minor skin irritation due tofassociated with dia 2 percent of volatile oil of mustard in alcohol and is known to per rash and helps protect from/seal out wetness. be used as a counter-irritant. 0.136. A less detailed list of additional counter-irritants 0129. Another counter-irritant is thyme oil (B.P.C. 1949) that can be used in the compositions described herein (01. Thym.; Esencia de tomillo) Dose: 0-06 to 0-3 ml. (1 to 5 includes: minims). Physically, it is a yellow or dark, reddish-brown liquid with a strong pleasant odour and a biting, persistent, 0.137 (a) mace (myristica fragrams; mace butter is cooling taste, obtained by distillation from the leaves and reported as being employed as a mild counter-irritant and flowering tops of Thymus vulgaris and other species of Thy used in hair lotions and plasters); mus and of species of Origanum (Labiatae). It contains not less than 40% V/v of phenols (thymol and carvacrol). Wit per 0.138 (b) black pepper extract and oil (used topically as a ml. 0-900 to 0-955 g. soluble 1 in 2 of alcohol (80%). Thyme counter-irritant, but that means it can cause significant skin oil has antiseptic, antispasmodic, and carminative properties irritation (Source: Natural Medicines Comprehensive Data and externally it has been employed as a counter-irritant. It is base, www.naturaldatabase.com)); described in various Pharmacopeias including Chil., Dan. 0.139 (c) calamine (a preparation of zinc carbonate, col Fr. Ger., Hung. Jug., Mex. Nor. Pol. Span., and Swiss (all ored with ferric oxide (a form of rust); Zinc carbonate is from T. vulgaris only); and Jap. (From T. vulgaris and other considered a counter-irritant and is used to reduce itching); species of Thymus). Also in U.S.N.F. (from T. vulgaris and other species of Thymus). 0140 (d) Szechuan peppercorn (from a plant native to the 0130. Another counter-irritant is allantoin. Allantoin is Szechuan Province in China; it grows on trees, and so differs derived from the comfrey root. It is a white, odorless, crys from black pepper, which grows on climbing vines; is known talline powder that is soluble in water and alcohol. It has been for the "numbing sensation it produces on the tongue and is characterized as a counter irritant that helps alleviate the considered a counter-irritant); irritating effects of soap, Surfactants, oils, acidic and alkaline 0.141 (e) camphor (an aromatic substance obtained from ingredients. It also is reported to hasten the healing processes the wood of a Southeast Asian tree, Cinnamomum camphora, of the body, helping the skin to help itself. In texts such as the or manufactured synthetically; when applied to the skin it Merck Index, British Pharmaceutical Codex and the United produces a cooling effect and dilates blood vessels, which can States Dispensatory it has also been termed a cell proliferant, cause skin irritation and dermatitis with repeated use chemical debrider and epithelization stimulant. It has been (Sources: British Journal of Dermatology, November 2000, said that allantoin can clean away necrotic tissue, speeding pages 923-929; and Clinical Toxicology, December 1981, the growth of new healthy tissue. The US FDA has only pages 1485-1498)); recognized allantoin as a skin protectant, not as a wound healing agent. As a skin protectant, allantoin has long been 0.142 (f) capsicum (a large group of plants consisting pri known to enhance creams and lotions. While allantoin can be marily of the pepper family, including chili peppers and used in OTC products (cosmeceuticals) and statements made paprika; used as counter-irritants to relieve muscleaches); about its properties, when added to a cosmetic product and no claims are made, the product remains a cosmetic. It is recom 0.143 (g) eucalyptus extract and oil (can have antibacte mended to use it at a rate of 0.5-2.0% w/w. Small concentra rial, antifungal, and antiviral properties on the skin (Source: tions can be added to the water phase, to incorporate more Skin Pharmacology and Applied Skin Physiology, January than 0.5% into an emulsion, add during the cooling phase February 2000, pages 60-64); can also be a skin irritant, once the temperature has dropped below 50° C./122°F. Its particularly on abraded skin (Sources: Clinical Experimental chemical name is glyoxyl-diureide, has a molecular weight of Dermatology, March 1995, pages 143-145; and www.alter 158.12, a melting range of 225°C., and a solubility in water nativedr.com/conditions/ConsHerbs/Eucalyptusch.html)); of 0.5% at 25° C. 0144. (h) menthyl lactate (used as a cooling agent and 0131 The U.S. FDA has classified Allantoin as a Category fragrance in cosmetics; it is a derivative of menthol and is I (safe and effective) active ingredient skin protectant. The Supposed to be less irritating than menthol); US 2008/01 07742 A1 May 8, 2008

0145 (i) eucalyptus extract (can have antibacterial, anti 0.160 Thickening Agents fungal, and antiviral properties on the skin (Source: Skin 0.161 Any suitable thickening agent as is known in the art Pharmacology and Applied Skin Physiology, January-Febru may be used in the compositions. For example, Suspending ary 2000, pages 60-64); can also be a skin irritant, particularly and thickening agents typically include waxes, silica gels, on abraded skin (Sources: Clinical Experimental Dermatol gums, clays, fumed silica, fatty acid soaps, and various hydro ogy, March 1995, pages 143-145); may be derived from the carbon gels. Hydrocarbon gels comprising di-block, tri major constituent in eucalyptus leaves is a volatile oil known block, multi-block and/or radial or star block copolymers are as eucalyptol (1,8-cineol)); and www.alternativedr.com/con used in the art as gelling agents or Suspending and dispersing ditions/ConsHerbs/Eucalyptusch.html)); agents. See U.S. Pat. No. 5,756,082, WO 98/42298, and EP 0 0146 () methyl salicylate (a counter irritant used in lini 497 144 B1, the disclosures of which are hereby incorporated ments; the primary ester in the flavour “Oil of wintergreen”: by reference. Copolymers of this type are known in the art to causes a mild irritating action on the skin and therefore acts as have advantageous properties when used as a Suspension a counter-irritant); agent for various solids and liquids. See WO 98/38981, the disclosure of which is hereby incorporated by reference. 0147 (k) chloral hydrate; Other thickening agents, as disclosed in U.S. Pat. No. 6,183, 0148 (1) 3-1-menthoxy propane-1,2-diol; 766, the contents of which are incorporated herein by refer ence, include one or more of polyacrylates; fumed silica, 0149 (m) N-substituted-p-menthane-3-carboxamides: natural and synthetic waxes, crystalline hydroxy-containing and waxes, alkyl silicone waxes; aluminium silicate; lanolin 0150 (n) acyclic carboxamides. derivatives; higher fatty alcohols; polyethylenecopolymers; narogel; polyammonium Stearate; Sucrose esters; hydropho 0151. For example, the following counter-irritants and bic clays; petrolatum; hydrotalcites; and mixtures thereof. their recommended amounts areas follows: camphor (greater Other thickeners include Sodium alginate, Xanthan gum, than 3 to 11 percent), hydrastis, menthol (1.25 to 16 percent), quince seed extract, tragacanth gum, starch, hydroxyethyl and turpentine oil (rectified) (6 to 50 percent). cellulose, methyl cellulose, carboxymethyl cellulose, 0152 Finally, the counter-irritants may be known as skin hydroxy propylmethyl cellulose, polyvinylpyrrolidone, poly sensates and are used herein interchangeably. Sensates and vinylalcohol, guar gum, hydroxypropyl guar gum, Soluble counter-irritants may be present at a level of from about starch, cationic celluloses, cationic guars, carboxyvinyl poly 0.01%to about 20%, typically from about 0.1% to about 10%, mers, polyvinylpyrrolidone, polyvinyl alcohol polyacrylic and particularly from about 0.2% to about 5%, and even more acid polymers, polymethacrylic acid polymers, polyvinyl particularly, at less than 1%. The level is selected to provide acetate polymers, polyvinyl chloride polymers, polyvi the desired level of consumer perceived sensation and can be nylidene chloride polymers, aluminium silicates, bentonites, modified as desired. Suitable sensate technologies include mixtures of polyethylene glycol and polyethylene glycol menthol, eucalyptus, 3-1-menthoxy propane-1,2-diol. stearate or distearate, hydrophobically modified celluloses N-Substituted-p-menthane-3-carboxamides and acyclic car and mixtures thereof. The thickener may be present at a boxamides, as well as the other counter-irritants described concentration of from about 0.1% to about 5%, or up to 15% above. for Some formulations depending on the need. 0153 3-1-menthoxypropane 1,2-diol is fully described in 0162 Moisturizers detail in U.S. Pat. No. 4,459,425, issued Jul. 10, 1984 to 0.163 Any suitable moisturizer as is known in the art may Amano et. al., incorporated herein by reference in its entirety. be used in the compositions. For example, as disclosed in U.S. This volatile aromatic is commercially available, being sold Pat. No. 6,183,766, the contents of which are incorporated by Takasago Perfumery Co., Ltd., Tokyo, Japan. herein by reference, lipophilic moisturizing agents include petrolatum, mineral oil, micro-crystalline waxes, polyalk 0154) The N-substituted-p-menthane-3-carboxamides are enes, paraffin, cerasin, oZokerite, polyethylene, perhy fully described in U.S. Pat. No. 4,136,163 to Watson et al., drosqualene, dimethicones, cyclomethicones, alkyl silox issued Jan. 23, 1979 incorporated herein by reference in its anes, polymethylsiloxanes, methylphenylpolysiloxanes, entirety. The most preferred volatile aromatic of this class is hydroxylated milk glyceride, castor oil, soybean oil, male N-ethyl-p-menthane-3-carboxamide which is commercially ated Soy bean oil, safflower oil, cotton seed oil, corn oil, available as WS-3 from Wilkinson Sword Limited. walnut oil, peanut oil, olive oil, cod liver oil, almond oil, 0155 Useful acyclic carboxamides are fully described in avocado oil, palm oil, sesame oil, liquid Sucrose octaesters, U.S. Pat. No. 4,230,688 to Rowsell et al., issued Oct. 28, 1980 blends of liquid Sucrose octaesters and solid polyol polyes incorporated herein by reference in its entirety. The most ters, lanolin oil, lanolin wax, lanolin alcohol, lanolin fatty preferred volatile aromatic of this class is N,2,3-trimethyl-2- acid, isopropyllanolate, acetylatedlanolin, acetylatedlanolin isopropylbutanamide which is commercially available as alcohols, lanolin alcohol linoleate, lanolin alcohol WS-23 from Wilkinson Sword Limited. riconoleate, beeswax, beeswax derivatives, spermaceti, myri styl myristate, Stearyl Stearate, carnauba and candelilla 0156 Fillers waxes, cholesterol, cholesterol fatty acid esters and homologs thereof, lecithin and derivatives, Sphingo lipids, ceramides, 0157 Any suitable filler as is known in the art may be used glycosphingo lipids and homologs thereof, and mixtures in the compositions. thereof. 0158 Preservatives 0164 Colorants 0159. Any suitable preservative as is known in the art may 0.165 Any suitable colorant as is known in the art may be be used in the compositions. used in the compositions. US 2008/01 07742 A1 May 8, 2008

0166 Emulsifiers tion under the trademark “Lubrajel”. The “Lubrajels' identi 0167 Any suitable emulsifier as is known in the art may be fied as “Lubrajel DV”, “Lubrajel MS’, and “Lubrajel CG” used in the compositions. For example, lanolin and lanolin may be used. derivatives may be used as emulsifiers, stabilizers, emol 0.175 Humectants are may be present, if used, in the com lients, moisturizers and absorption bases. They have been positions at concentrations of from about 0.01% to about used in applications such as creams, lotions, liquid make-up 15%, particularly from about 0.5% to about 10%, and more and general purpose cosmetics. Examples of lanolins and particularly at from about 1% to about 6%. derivatives include: anhydrous lanolin USP polysorbate 80 and cetyl acetate and acetylated lanolin alcohol, cetyl acetate 0176 Alkalinizing Agents and acetylated lanolin alcohol, lanolin alcohol, PPG-12 0177. Any suitable alkalinizing as is known in the art may PEG-50 lanolin, PPG-12-PEG-65 lanolin, hydroxylated be used in the compositions. lanolin; PEG 60 lanolin; PEG 75 lanolin, PEG 75 lanolin and water, mineral oil/lanolin alcohol, acetylated lanolin, lanolin 0.178 Stabilizers oil. In formulating the composition, the emulsifying agent may be made up of emulsifying Surfactants in which at least 0179 EDTA. ethylenediaminetetraacetic Abbreviation one emulsifying surfactant has an HLB value below 12 and at for ethylenediaminetetraacetic acid. It is a stabilizer used in least one emulsifying surfactant has an HLB value of 12 or cosmetics to prevent ingredients in a given formula from above. binding with trace elements (particularly minerals) that can exist in water and other ingredients to cause unwanted prod 0168 Emulsifiers and other ingredients may be used to uct changes such as texture, odor, and consistency problems. provide a viscosity suitable to the desired use. For example, if The technical term for this function is a chelating agent. the composition is in the form of an emulsion and more Additional references, each of which is incorporated herein in especially in the form of a W/O emulsion, especially in the their entirety by reference, are provided to further describe form of a fluid emulsion, i.e., an emulsion having a viscosity suitable stabilizers and their characteristics: ranging from 60 to 600 cB (60 to 600 mPa's) and better still from 80 to 250 cB (80 to 250 mPa's), the viscosity being http://chem.sis.nlm.nih.gov/chemidplus/detail frame.html measured using a Metier RM180 viscometer (Rheomat) with '?DetailIndex=1&DetailCount=1: an M2 spindle, at 25°C. and at a speed of 200 rpm. A fairly fluid emulsion is thus obtained, which is very pleasant to use http://householdproducts.nlm.nih.gov/cgi-bin/household/ since it spreads easily. brands?tbl=chem'96id=888; 0169. Wetting Agents http://www.gujchem.com/ http://www.ghp.org.uk/defaul t.asp?channel id=398&editorial id=6123; and http://www 0170 Any suitable wetting agent as is known in the art .cosmeticsop.com/learn/dictionary.asp?TYPE=FIND. may be used in the compositions. 0171 Detergents 0180 Antibacterial Agents 0181 Further, as described above, the compositions can 0172 Any suitable detergent as is known in the art may be include antibacterial agents and antimicrobial agents. Anti used in the compositions. microbial agents suitable for use are described in U.S. Pat. 0173 Humectants Nos.: 5,686,089: 5,681,802, 5,607,980, 4,714,563: 4,163,800; 3,835,057; and 3,152,181; all of which are herein 0174 Humectants also may be used in the compositions incorporated by reference in their entirety. When incorpo described herein. Humectants function to retain water on the rated herein the antimicrobial agent is preferably present, if skin Surface. Examples of Some humectants include polyhy used, at a concentration of from about 0.001% to about 5%, dric alcohols selected from the group consisting of ethylene more preferably 0.05% to about 1%, even more preferably glycol, propylene glycol, dipropylene glycol, butylene gly from about 0.05% to about 0.5%, and most preferably 0.1% to col, hexylene glycol, polyethylene glycols, glycerin, Sorbitol, about 0.5%. panthenols, urea, alkoxylated glucose derivatives. Such as Glucam (RTM) E-20, hexanetriol, glucose ethers, sodium 0182 Also useful as antimicrobial agents are the so-called hyaluronate, soluble chitosan and mixtures thereof. Glycerin “natural antibacterial actives, referred to as natural essential may be, for example, “glycerin, USP 99.5%, which is sold oils. These actives derive their names from their natural by Dow Chemical, Inc., Emery Industries, Inc. (under the occurrence in plants. Typical natural essential oil antibacte name “Superol 99.5%), and Procter & Gamble. Another rial actives include oils of anise, lemon, orange, rosemary, humectant is “DL-panthenol, which is sold by Hoffman wintergreen, thyme, lavender, cloves, hops, tea tree, cit Laroche. Yet another humectant is PEG/PPG 17/6 copolymer ronella, wheat, barley, lemongrass, cedar leaf cedarwood, (17 moles ethylene oxide/6 moles propylene oxide), prefer cinnamon, fleagrass, geranium, Sandalwood, violet, cran ably that sold by PPG/Mazer Chemicals or Union Carbide, berry, eucalyptus, Vervain, peppermint, gum benzoin, basil, under the names “Macol 450 and “Ucon 75-H-450. Still fennel, fir, balsam, menthol, ocmea Origanum, Hydastis car another humectant is phytantriol, preferably that sold by radensis, Berberidaceae daceae, Ratanhiae and Curcuna Roche. Also polyglycerylmethacrylate lubricants having a longa. Also included in this class of natural essential oils are viscosity at 25°C. of 300,000 to 1,100,000 mPas; a specific the key chemical components of the plant oils which have gravity at 25.degree. C. of 1 to 1.2 g/ml, a pH of 5.0 to 5.5; a been found to provide the antimicrobial benefit. These chemi bound water content of 33 to 58%; and, a free water content cals include, but are not limited to anethol, catechole, cam from 5 to 20% may be used. Suitable polyglycerylmethacry phene, carvacol, eugenol, eucalyptol, ferulic acid, farnesol, late lubricants are marketed by Guardian Chemical Corpora hinokitiol, tropolone, limonene, menthol, methyl salicylate, US 2008/01 07742 A1 May 8, 2008

thymol, terpineol, Verbenone, berberine, ratanhiae extract, resins buffered, Beeswax, Benzethonium chloride, Ben caryophellene oxide, citronellic acid, curcumin, nerolidol Zocaine (0.5 to 1.25 percent), Benzocaine Bithionol, Benzyl and geraniol. alcohol, Bismuth submitrate, Bithionol, Boric acid, Calamine, Camphor, Cetalkonium chloride, Cetyl alcohol, Cyclom 0183. Additional antimicrobial agents are antibacterial ethycaine sulfate, Chloral hydrate, Chlorobutanol, Chlorphe metal salts. This class generally includes salts of metals in niramine maleate, Creosote, Creosote (beechwood), Dexpan groups 3b-7b, 8 and 3a-5a. Specifically included are the salts thenol, Diperodon hydrochloride, Diphenhydramine of aluminum, Zirconium, Zinc, silver, gold, copper, lantha hydrochloride, Eucalyptus oil, Eugenol, Ferric chloride, num, tin, mercury, bismuth, selenium, strontium, Scandium, Glycerin, Glyceryl Stearate, Glycol salicylate, Hectorite, yttrium, cerium, praseodymium, neodymium, promethium, Hexylresorcinol, Hydrogen peroxide, Impatiens biflora tinc Samarium, europium, gadolinium, terbium, dysprosium, hol ture, Iron oxide, Isopropyl alcohol, Isopropyl palmitate, mium, erbium, thulium, ytterbium, lutetium and mixtures Lanolin, Lead acetate, Lidocaine, Live yeast cell derivative, thereof. Menthol, Merbromin, Mercuric chloride, Methapyrilene 0184 Preferred antimicrobial agents include piroctone hydrochloride, Panthenol, Parethoxycaine hydrochloride, olamine (hereinafter OctopiroXR) available from Hoechst Phenol, Phenyltoloxamine dihydrogen citrate, Povidone-vi AG; 2,4,4-trichloro-2'-hydroxy diphenylether (hereinafter nylacetate copolymers, Pyrilamine maleate, Salicylamide, “TCS or “Triclosan(R) available from Ciba-Geigy Corp.; Salicylic acid, Simethicone, Shark liver oil, Stearyl alcohol, 3,4,4-trichlorocarbanilide (hereinafter “TCC” or “Triclocar Sulfur, Tannic acid, Thymol, Topical starch, Trolamine, Tro ban R”) available from Bayer AG; para-chloro-meta-xylenol lamine Salicylate, Turpentine oil, Zirconium oxide, and (hereinafter PCMX) available from Rhone Poulenc, Zinc Zyloxin; pyrithione (hereinafter “ZPT) available from the Olin Corp.; 0191 (b) for labeling for fever blister and cold sore treat 1-phenoxypropan-2-ol available from Nippa Laboratories ment: Allyl isothiocyanate, Aspirin, Bismuth sodium tartrate, Ltd.; benzalkonium chlorides and/or substituted benzalko Camphor (exceeding 3 percent), Capsaicin, Capsicum, Cap nium chlorides such as those available from Lonza under the sicum oleoresin, Chloral hydrate, Chlorobutanol, Cyclom tradename BarquatR; benzoyl peroxide, erythromycin, tetra ethycaine Sulfate, Eucalyptus oil, Eugenol, Glycol salicylate, cycline, clindamycin, azelaic acid, Sulfur compounds such as Hexylresorcinol, Histamine dihydrochloride, Menthol Sulfonamides, resorcinol, essential oils and their key ingredi (exceeding 1 percent), Methapyrilene hydrochloride, Methyl ents and mixtures thereof. Also useful herein is the antimi nicotinate, Methyl salicylate, Pectin, Salicylamide, Strong crobial compositions described in PCT Applications WO98/ ammonia solution, Tannic acid, Thymol, Tripelennamine 55080 and WO98/55081, Baier et al., both published Dec. 10, hydrochloride, Trolamine salicylate, Turpentine oil, and Zinc 1998, both of which are herein incorporated by reference in its entirety. sulfate; 0.192 (c) for labeling for insect bite and sting: Alcohol: 0185 Antifungal Agents Alcohol, ethoxylated alkyl, Ammonia Solution (strong); 0186 Also useful in the compositions described herein are Ammonium hydroxide; Benzalkonium chloride; Calamine; antifungal agents. Suitable antifungal agents include, in par Camphor; Ergot fluid extract; Ferric chloride: Menthol; Pan ticular compounds belonging to the imidazole class Such as thenol; Peppermint oil; Pyrilamine maleate; Sodium borate; clotrimazole, econazole, ketoconazole, fluconazole, or Trolamine salicylate; Turpentine oil; Zinc oxide; and Zirco miconazole or salts thereof, polyene compounds such as nium oxide; Phenol; Beeswax; Bismuth submitrate; Boric amphotericin B, compounds of the allylamine family Such as acid; Cetyl alcohol; Glyceryl Stearate; Isopropyl palmitate; terbinafine, or octopirox. Also useful herein are naftifine, Live yeast cell derivative: Shark liver oil; and Stearyl alcohol. tolnaftate, nystatin, 5-fluorocytosine, griseofulvin, and halo 0193 (d) for labeling for external analgesic drug products: progin. Mixtures of the above antifungals can also be used. A Chloral hydrate, Chlorobutanol, Cyclomethycaine sulfate, detailed discussion of antifungals as well as additional Eugenol, Hexylresorcinol, Methapyrilene hydrochloride, examples can be found in Remington's pharmaceutical Sci Salicylamide, and Thymol. ences, 17th ed. (Alfonso R. Gennaro ed., 1985) pp. 1225 1231, herein incorporated by reference. 0194 While several particular forms of the inventions have been illustrated and described, it will be apparent that 0187 When incorporated in the compositions, the antifun various modifications can be made without departing from gal agent may be present at a concentration of from about the spirit and scope of the invention. For example, even if not 0.001% to about 5%, more particularly at 0.05% to about 1%, specifically indicated, any of the ingredients described above even more particularly at from about 0.05% to about 0.5%, can be included in the compositions or excluded from the and still more particularly at 0.1% to about 0.5%. compositions. Accordingly, it is not intended that the inven 0188 Approved FDA Ingredient tion be limited, except as by the appended claims. 0189 Finally, the compositions described herein may spe 1.-11. (canceled) cifically include an ingredient accepted or approved by the 12. A method for treating a condition caused by the contact FDA (defined herein as an “approved FDA ingredient') in a of skin with a source of urushiol, the method comprising: monograph or for OTC usage such that the product can be providing a topical scrub intended to be applied to skin that labeled for treatment of poison ivy, poison oak, or poison has been in contact with the source of urushiol, the Sumac. The approved FDA ingredients, as defined herein are topical scrub comprising: the following: one or more Surfactants; 0.190 (a) for labeling for poison ivy, poison oak, and poi one or more granular materials configured to roughen son Sumac drug products: alcohol, anion and cation exchange skin that has been in contact with urushiol and provide US 2008/01 07742 A1 May 8, 2008 15

a sensation on the skin that causes at least Some relief skin and the one or more counterirritants provide a sen of the itching caused by the urushiol upon a scrubbing sation on the skin to which the topical scrub has been application of the topical Scrub; and applied. 22. The method of claim 21, wherein the one or more one or more counterirritants, whereby the one or more Surfactants comprises one or both of an anionic Surfactant and Surfactants is used in removing the urushiol from the a nonionic Surfactant. skin and the one or more counterirritants provide a 23. The method of claim 21, wherein the one or more sensation on the skin to which the topical scrub has counterirritants comprise one or both of menthol and cam been applied; phor. Scrubbing the skin with the topical scrub to cause a rough 24. The method of claim 21, wherein the one or more ening of the skin; and granular materials have a diameter greater than 50 microns. 25. The method of claim 21, further comprising one or removing the topical scrub from the skin. more additional agents selected from the group consisting of 13. The method of claim 12, further comprising one or antifungal agents, antibiotic agents, and antiviral agents. more of an alkalinizing agent, humectant, detergent, wetting 26. The method of claim 21, wherein the granular material agent, antibacterial agent, stabilizer, emulsifier, antifungal comprises one or more of granules, beads, microspheres, grit, agent, colorants, moisturizer, thickening agent, preservative, and pumice. filler, keratolytic agent, protectant agent, vasoconstrictor 27. The method of claim 21, wherein the granular material agent, astringent agent, local anesthetic agent, analgesic/an comprises one or more of a polymer, sand, glass, and jojoba esthetic/antipruritic agents, antiviral agent, and wound heal beads. ing agent. 28. The method of claim 27, wherein the polymer com 14. The method of claim 12, wherein the one or more prises one or more of a polyethylene, a polypropylene, and a counterirritants comprise one or both of menthol and cam polystyrene. phor. 29. The method of claim 21, wherein the granular material 15. The method of claim 12, wherein the one or more is porous. granular materials have a diameter greater than 50 microns. 30. The method of claim 21, wherein the granular material 16. The method of claim 12, wherein the granular material is a pad, cloth or other scrubbing means. comprises one or more of granules, beads, microspheres, grit, 31. A kit for removing urushiol from skin, the kit compris pumice, polymer, Sand, glass, and jojoba beads. 1ng: 17. The method of claim 12, wherein the granular materials comprise a pad, cloth or scrubbing means. a topical Scrub for removing urushiol from skin by using 18. The method of claim 12, wherein the contact with the the topical scrub to Scrub skin that has been in contact urushiol occurred more than 24 hours before the application with urushiol, the topical scrub comprising: of the topical scrub. one or more Surfactants; 19. The method of claim 12, wherein the contact with the one or more granular materials configured to roughen skin urushiol occurred more than 72 hours before the application that has been in contact with urushiol and provide a of the topical scrub. sensation on the skin that causes at least some relief of 20. The method of claim 12, wherein the topical scrub is the itching caused by the urushiol upon a scrubbing applied to a rash formed by the contact with the urushiol. application of the topical scrub; and 21. A method of treating a rash caused by contact with urushiol, the method comprising providing a topical scrub for one or more counterirritants, whereby the one or more removing urushiol from skin by using the topical Scrub to Surfactants is used in removing the urushiol from the scrub skin that has been in contact with urushiol, the topical skin and the one or more counterirritants provide a sen scrub comprising: sation on the skin to which the topical scrub has been applied; one or more Surfactants; the topical scrub being in a container for dispensing the one or more granular materials configured to roughen skin topical scrub; and that has been in contact with urushiol and provide a sensation on the skin that causes at least some relief of the container including instructions for use for instructing the itching caused by the urushiol upon a scrubbing how to apply the topical scrub to remove the urushiol application of the topical scrub; and from the skinto treat the rash resulting from contact with urushiol. one or more counterirritants, whereby the one or more Surfactants is used in removing the urushiol from the